Ticagrelor Msn

Package Leaflet: Information for the User

Ticagrelor MSN, 90 mg, Coated Tablets

Ticagrelor

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Ticagrelor MSN and what is it used for
• 2. Important information before taking Ticagrelor MSN
• 3. How to take Ticagrelor MSN
• 4. Possible side effects
• 5. How to store Ticagrelor MSN
• 6. Contents of the pack and other information

1. What is Ticagrelor MSN and what is it used for

What is Ticagrelor MSN

Ticagrelor MSN contains the active substance ticagrelor. It belongs to a group of medicines called antiplatelet medicines.

What is Ticagrelor MSN used for

Ticagrelor MSN, in combination with acetylsalicylic acid (another antiplatelet medicine), is used only in adults who have had:

• heart attack or
• unstable angina (chest pain or discomfort which is not well controlled). The medicine reduces the chance of having another heart attack or stroke, or dying from a heart or blood vessel-related problem.

How Ticagrelor MSN works

Ticagrelor MSN works by affecting cells in the blood called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking the damaged area of the blood vessel. However, platelets can also form clots in narrowed blood vessels in the heart and brain, which can lead to a heart attack or stroke.

• a clot can completely block the blood flow, which can cause a heart attack (myocardial infarction) or stroke, or
• a clot can partially block the blood flow to the heart, reducing blood flow to the heart and causing chest pain (unstable angina).

Ticagrelor MSN helps prevent platelets from clumping together and forming clots, reducing the chance of a clot blocking the blood flow.

2. Important information before taking Ticagrelor MSN

When not to take Ticagrelor MSN:

• If you are allergic to ticagrelor or any of the other ingredients of Ticagrelor MSN (listed in section 6).
• If you are currently bleeding.
• If you have had a stroke caused by bleeding in the brain.
• If you have severe liver disease.
• If you are taking any of the following medicines:
• ketokonazole (used to treat fungal infections)
• clarithromycin (used to treat bacterial infections)
• nefazodone (an antidepressant)
• ritonavir and atazanavir (used to treat HIV and AIDS) Do not take Ticagrelor MSN if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Ticagrelor MSN, tell your doctor or pharmacist if:

• you have an increased risk of bleeding due to:
• a recent serious injury
• recent surgery (including dental surgery - consult your dentist)
• a disease that affects blood clotting
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps)
• you will be having surgery (including dental surgery) at any time while taking Ticagrelor MSN. This is because of the increased risk of bleeding. Your doctor may advise you to stop taking the medicine 5 days before the planned surgery.
• you have a slow heart rate (usually less than 60 beats per minute) and do not have a pacemaker.
• you have asthma or other lung disease or breathing difficulties.
• you develop breathing difficulties such as rapid breathing, slow breathing, or pauses in breathing. Your doctor will decide if further evaluation is needed.
• you have any liver problems or have had a disease in the past that may have damaged your liver.
• your blood test results show high levels of uric acid. Consult your doctor or pharmacist before taking this medicine if any of the above apply to you (or if you are unsure).

If you are taking Ticagrelor MSN and heparin:

• your doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is important to inform your doctor that you are taking both Ticagrelor MSN and heparin, as Ticagrelor MSN may affect the test results.

Children and adolescents

Ticagrelor MSN should not be used in children and adolescents under 18 years of age.

Ticagrelor MSN with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take. This is because Ticagrelor MSN may affect the way other medicines work, and other medicines may affect the way Ticagrelor MSN works.

• rosuvastatin (a medicine used to lower cholesterol levels)
• simvastatin or lovastatin in doses greater than 40 mg per day (medicines used to lower cholesterol levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control seizures)
• digoxin (used to treat heart failure)
• cyclosporin (used to weaken the immune system)
• quinidine and diltiazem (used to treat irregular heart rhythms)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

Particularly, inform your doctor or pharmacist if you are taking any of the following medicines that increase the risk of bleeding:

• oral anticoagulants, often referred to as blood thinners, including warfarin
• non-steroidal anti-inflammatory drugs (NSAIDs), often used as painkillers, such as ibuprofen and naproxen
• selective serotonin reuptake inhibitors (SSRIs), used as antidepressants, such as paroxetine, sertraline, and citalopram
• other medicines, such as ketokonazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches)

Also, inform your doctor if you are taking Ticagrelor MSN and are at increased risk of bleeding, if your doctor prescribes fibrinolytic medicines, often referred to as clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticagrelor MSN should not be used during pregnancy or if you are planning to become pregnant. While taking this medicine, women should use appropriate contraceptive methods to prevent pregnancy.

Before taking this medicine, inform your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of taking Ticagrelor MSN while breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is unlikely that Ticagrelor MSN will affect your ability to drive or use machines. However, if you experience dizziness or confusion while taking this medicine, be careful when driving or using machines.

3. How to take Ticagrelor MSN

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

How much to take

Ticagrelor MSN, 90 mg, coated tablets:

• The starting dose is two tablets taken at the same time (a loading dose of 180 mg). This dose is usually given in a hospital.
• After the starting dose, the usual dose is one 90 mg tablet taken twice a day for up to 12 months, unless your doctor tells you otherwise.
• It is recommended to take the medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Ticagrelor MSN with other blood-thinning medicines

Your doctor will usually recommend taking acetylsalicylic acid as well. This is a substance found in many medicines that prevent blood clotting. Your doctor will tell you what dose to take (usually between 75 and 150 mg per day).

How to take Ticagrelor MSN

• Tablets can be taken with or without food.
• You can check when you last took a tablet by looking at the blister pack. The blister pack has a sun symbol (for morning doses) and a moon symbol (for evening doses). These symbols help you remember when you took your last dose.

What to do if you have difficulty swallowing the tablet

If you have difficulty swallowing the tablet, you can crush it and mix it with water as follows:

• Crush the tablet into a fine powder.
• Put the powder into half a glass of water.
• Mix and drink immediately.
• To make sure you take all the medicine, refill the glass with half a glass of water, swirl, and drink. If you are being treated in a hospital, the tablet can be mixed with water and given through a nasogastric tube.

What to do if you take more Ticagrelor MSN than you should

If you take more Ticagrelor MSN than you should, contact your doctor or go to the hospital immediately. Take the medicine pack with you. You may be at increased risk of bleeding.

What to do if you forget to take Ticagrelor MSN

• If you forget to take a dose, take the next dose at the usual time.
• Do not take a double dose (two doses at the same time) to make up for the forgotten dose.

What to do if you stop taking Ticagrelor MSN

Do not stop taking Ticagrelor MSN without talking to your doctor. You should take the medicine regularly and for as long as your doctor tells you. Stopping Ticagrelor MSN may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related problem.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ticagrelor MSN can cause side effects, although not everybody gets them.

When taking this medicine, the following side effects may occur:

Ticagrelor MSN affects blood clotting, and most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g., bruising and nosebleeds). Severe bleeding is less common but can be life-threatening.

Seek medical help immediately if you experience any of the following symptoms - you may need urgent medical attention:

• Bleeding in the brain or within the skull is an uncommon side effect and may cause stroke-like symptoms, such as:
• sudden numbness or weakness of the arms, legs, or face, especially if it occurs on one side of the body
• sudden confusion, difficulty speaking or understanding others
• sudden difficulty walking, loss of balance, or coordination
• sudden dizziness or severe headache with no known cause
• Signs of bleeding, such as:
• heavy or prolonged bleeding
• unexpected or prolonged bleeding
• urine that is pink, red, or brown
• vomiting blood or material that looks like coffee grounds
• stools that are black or tarry
• coughing or vomiting blood clots
• Fainting
• temporary loss of consciousness due to a sudden decrease in blood flow to the brain (common)
• Signs of a blood clotting disorder called thrombotic thrombocytopenic purpura (TTP), such as:
• fever and purple spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained severe tiredness or confusion

Tell your doctor if you experience:

• Shortness of breath (dyspnea) - very common. It may be caused by heart disease or another condition, or it may be a side effect of Ticagrelor MSN. Dyspnea related to Ticagrelor MSN is usually mild and characterized by sudden, unexpected shortness of breath, often at rest, which may occur during the first few weeks of treatment and then not occur for many weeks. If dyspnea worsens or persists, contact your doctor. Your doctor will decide if treatment or further evaluation is needed.

Other possible side effects

Very common (may affect more than 1 in 10 people)

• Increased uric acid levels in the blood (found in laboratory tests)
• Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or lightheadedness
• Diarrhea or indigestion
• Nausea (feeling sick)
• Constipation
• Rash
• Itching
• Increased pain and swelling of the joints - these are symptoms of gout
• Dizziness or lightheadedness or blurred vision - these are symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts and wounds, which is more than usual
• Bleeding from the stomach lining (stomach ulcer)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction - rash, itching, swelling of the face or lips/tongue, which may be signs of an allergic reaction
• Disorientation (confusion)
• Vision disturbances caused by blood in the eye
• Vaginal bleeding, which is heavier or occurs at a different time than your regular menstrual bleeding
• Bleeding into the joints and muscles, causing painful swelling
• Blood in the ear
• Internal bleeding, which can cause dizziness or lightheadedness

Frequency not known (cannot be estimated from the available data)

• Abnormally low heart rate (usually less than 60 beats per minute)

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ticagrelor MSN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ticagrelor MSN contains

• The active substance is ticagrelor. Each tablet contains 90 mg of ticagrelor.
• The other ingredients are: Core:mannitol (E 421), hydroxypropylcellulose, calcium hydrogen phosphate dihydrate, hydroxypropylcellulose (E 463) (contains silicon dioxide), magnesium stearate (E 470b).

Coating:
hypromellose 2910 (E 464), titanium dioxide (E 171), macrogol 400 (E 1521), talc (E 553b),
yellow iron oxide (E 172).

What Ticagrelor MSN looks like and contents of the pack

Yellow, round, biconvex, coated tablets (about 9 mm in diameter), with the inscription "90 and M" on one side and smooth on the other.

Ticagrelor MSN is available in:

• standard blisters (with sun/moon symbols) in cardboard boxes of 60, 100, and 180 tablets.
• calendar blisters (with sun/moon symbols) in cardboard boxes of 14, 56, and 168 tablets.
• perforated unit-dose blisters of 10 tablets; cardboard boxes of 60 x 1, 100 x 1, and 180 x 1 tablet.
• perforated unit-dose blisters of 14 tablets; cardboard boxes of 14 x 1, 56 x 1, and 168 x 1 tablet.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147

Manufacturer/Importer:

MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta
Pharmadox Healthcare Limited
KW20A, Kordin Industrial Park
Paola, PLA 3000
Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Hungary:
Ticagrelor MSN 90 mg film-coated tablet
Czech Republic:
Ticagrelor MSN
Poland:
Ticagrelor MSN
Slovakia:
Ticagrelor MSN 90 mg
Romania:
Ticagrelor MSN 90 mg film-coated tablets
Bulgaria:
Тикагрелор MSN 90 mg филмирани таблетки

Date of last revision of the package leaflet: